欧盟RAPEX系统通报情况分析及对我国化妆品原料管理的启示  

Information bulletin analysis of EU RAPEX system and enlightenment to cosmetic ingredient management in China

作　　者：黄湘鹭[1] 卢家灿 邢书霞[1] 孙磊[1] Xianglu Huang;Jiacan Lu;Shuxia Xing;Lei Sun(National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《日用化学工业》2022年第6期638-644,共7页China Surfactant Detergent & Cosmetics

摘　　要：分析欧盟非食品类消费产品快速预警系统(RAPEX系统)通报的化妆品情况,对具有化学风险的产品进行重点分析,为制定与完善中国化妆品原料管理措施提供参考。汇总2005年至2021年欧盟RAPEX系统通报的化妆品情况,对违规情况进行归类分析。2005年2月至2021年5月,REPEX系统共通报具有化学风险的化妆品364件,涉及违规物质92种,需要引起重视的物质包括美白剂、防腐剂、致敏性香精香料、染发剂、着色剂、重金属和药物成分。建议针对氢醌、甲基氯异噻唑啉酮和甲基异噻唑啉酮与氯化镁及硝酸镁的混合物、汞,加强相关产品上市后监管力度;加强或明确曲酸、致敏性香精香料、比马前列素等原料管理要求;加大防腐剂和染发剂规范使用的培训力度,对于甲基氯异噻唑啉酮和甲基异噻唑啉酮与氯化镁及硝酸镁的混合物和甲基异噻唑啉酮等行业使用较多且易发生违规行为的原料,制定相应原料技术标准;针对重金属原料(如镍、锆、锑、铬、钴等)开展风险监测,必要时制定管理措施;建议在新原料注册备案中予以关注着色剂CI 45161、CI 45174和溶剂黄172;参考欧盟灵活通报和处置机制,对具有安全风险的原料及时采取控制措施。The aim was to analyze the cosmetic information bulletin of EU RAPEX,focusing on the analysis of products with chemical risks,and to provide reference for cosmetic ingredient management.The data from EU RAPEX system in 2005-2021 were summarized.The violations of the products were analyzed.According to the illegal substance,product type,country of origin and reason of violation,the notified results were analyzed statistically.Comparative analysis was made on the management of the notified substances according to the relevant information in European Union and China cosmetics ingredient management.At the same time,according to the whitening agent,preservative,flavor and fragrance,hair colorant,colorant,heavy metal,drug composition and other different categories of in-depth interpretation,its enlightenment was explored to the management of cosmetics raw materials in China.From February 2005 to May 2017,the REPEX system notifies 364 cosmetic products with chemical risk,involving 92 substances with violations.The most frequently reported violation is the addition of hydroquinone for skin-lightening products.Perfume is the most frequently reported product type.The main reason for violation is not as requiring to mark allergenic flavor fragrance.The most frequently reported country of origin is China,mainly because China does not have formulated management requirements for allergenic flavor fragrances,which leads to the labeling of flavor fragrances in China’s exported cosmetics does not meet the relevant requirements of the EU.The most frequently reported reasons for product violations are the detection or illegal addition of banned ingredients.Substances that need attention include whitening agents,preservatives,allergenic fragrances,hair colorants,colorants,heavy metal and pharmaceutical ingredients.Stronger post-marketing regulation of the related products is recommended for hydroquinone,Kathon and mercury.Strengthening or clarifying the requirements for raw material management such as kojic acid,allergenic flavor

关 键 词：RAPEX系统 化妆品 原料 安全 

分 类 号：TQ658[化学工程—精细化工]